NL-OMON32556已完成不适用
An Open-Label, Sequential Treatment Study to Assess the Single- and Multiple-Dose Pharmacokinetics of a New Tapentadol Prolonged-Release 250 mg Formulation in Healthy Subjects. - Open-label sequential treatment study with tapentadol.
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 18
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •1. Man or woman, 18 to 55 years of age, inclusive.
- •2. Signed informed consent.
- •3. Healthy on the basis of prestudy physical examination, medical history, 12-lead ECG, vital signs, and clinical laboratory parameters.
- •4. Received a thorough explanation of the optional pharmacogenomic research component of the study and was offered the opportunity to participate by signing the separate pharmacogenomic informed consent document.
- •5. Women must be postmenopausal, surgically sterile or be practicing an effective method of birth control.
- •6. Women must have a negative serum ß-human chorionic gonadotropin (ß-hCG) pregnancy test at screening.
- •7. Body mass index between 20 and 28 kg/m2 inclusive and body weight nog less than 50kg.
- •8. Blood pressure between 100 and 140 mmHg systolic, inclusive, and between 50 and 90 mmHg diastolic, inclusive.
- •9. Habitually smokes no more than 10 cigarettes, or 2 cigars, or 2 pipes of tobacco per day for at least 6 months before first study drug administration.
排除标准
- •1. History of seizure disorder or epilepsy or traumatic brain injury.
- •2. History of gastrointestinal disease affecting absorption, gastric surgery or
- •history of or current significant medical illness including (but not limited
- •to) cardiac arrhythmias or other cardiac disease, hematologic disease,
- •coagulation disorders (including any abnormal bleeding or blood
- •dyscrasias), lipid abnormalities, significant pulmonary disease (including
- •bronchospastic respiratory disease), diabetes mellitus, renal or hepatic
- •insufficiency, thyroid disease, neurologic or psychiatric disease,
- •infection, or any other illness that the investigator considers should
- •exclude the subject.
- •3. History of allergies.
- •4. History of drug or alcohol abuse.
- •5. Positive test for drug or alcohol abuse.
- •6. Donated blood, blood products or loss of blood (> 500 mL) within 2 months before the first administration of study drug.
- •7. Received an experimental drug or used an experimental medical device within 30 days or within a period less than 10 times the drug's half life before the first dose of the study drug is scheduled.
- •8. Women who plan to become pregnant during the study, or who are breast-feeding.
- •9. Men and women with abnormal hemoglobin concentrations.
- •10. Subjects who have used prescription medications and/or over-the-counter medication (incl. ibuprofen or herbal medication) within 14 days before first study drug administration, MAOI's and SNRIs within 21 days before first study drug administration, alcohol/grapefruit juice/quinine-containing drinks/seville orange products whithin 24 hours before first study drug administration, methylxanthine-containing products within 48 hours before first study drug administration.
- •11. Unable to swallow solid, oral dosage forms whole with the aid of water(participants may not chew, divide, dissolve, or crush the study drug).
- •12. Positive test for HIV and Hepatitis.
- •13. Preplanned surgery or procedures that would interfere with the conduct of the study.
- •14. Known or suspected inability to comply with the study protocol.
- •15. Inability to communicate meaningfully with investigator and staff.
- •16. Employee of the investigator or study center, as well as family member of the employees or investigator.
研究者
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